Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer

NCT06752811 | Recruiting Phase 3 DMC

• 1 other identifier: Shanghai Yizhong
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 2

Brief Summary

This trial is a multi-center, randomized, open, parallel-group and positive-controlled phase III trial to evaluate the efficacy and safety of paclitaxel polymeric micelles for injection plus gemcitabine as first-line treatment of metastatic pancreatic cancer compared with nab-Paclitaxel plus gemcitabine.

Conditions

Pancreatic Cancer Metastatic

Keywords

paclitaxel polymeric micelles for injection

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival

  PFS(Progression-Free-Survival) is the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurs first.

  Randomization to measured PD or date of death from any cause（up to 36 months)

Secondary Outcomes (4)

• Overall Survival(OS)

  Randomization to date of death from any cause（up to 36 months)

• Objective Response Rate(ORR)

  Baseline to measured PD（up to 36 months)

• Disease Control Rate（DCR）

  Baseline to measured PD（up to 36 months)

• Incidence of adverse events

  up to 36 months

Study Arms (2)

paclitaxel polymeric micelles for injection+Gemcitabine Hydrochloride for Injection

EXPERIMENTAL

Patients in the experimental group will receive intravenous infusion of paclitaxel polymeric micelles for injection at a dose of 300 mg/m2 (based on body surface area), administered on Day 1, with intravenous infusion for ≥ 3 hours, every 3 weeks as a cycle. Then, the subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1 and D8 every 3 weeks.

Drug: paclitaxel polymeric micelles for injection; Drug: Gemcitabine Hydrochloride for Injection

paclitaxel for injection(albumin bound )+Gemcitabine Hydrochloride for Injection

ACTIVE COMPARATOR

Control Group: Patients in the control group will receive intravenous infusion of paclitaxel (albumin bound) at a dose of 125 mg/m2 (based on body surface area), administered at D1, D8, and D15, every 4 weeks as a cycle. Then, the subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1, D8, and D15 every 4 weeks.

Drug: Paclitaxel for Injection (albumin bound ); Drug: Gemcitabine Hydrochloride for Injection

Interventions

paclitaxel polymeric micelles for injection DRUG

Paclitaxel polymeric micelles for injection at a dose of 300 mg/m2 (based on body surface area), administered on Day 1, with intravenous infusion for ≥ 3 hours, every 3 weeks as a cycle.

paclitaxel polymeric micelles for injection+Gemcitabine Hydrochloride for Injection

Gemcitabine Hydrochloride for Injection DRUG

The subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1 and D8 every 3 weeks.

paclitaxel polymeric micelles for injection+Gemcitabine Hydrochloride for Injection

Paclitaxel for Injection (albumin bound ) DRUG

Patients in the control group will receive intravenous infusion of paclitaxel for Injection (albumin bound ) at a dose of 125 mg/m2 (based on body surface area), administered at D1, D8, and D15, every 4 weeks as a cycle.

paclitaxel for injection(albumin bound )+Gemcitabine Hydrochloride for Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Men or women aged 18 to 75 years old (including the critical value).
• ）Metastatic pancreatic cancer confirmed by histology or cytology.
• ）Patients who have not previously received any systemic therapy (including chemotherapy, targeted, and immunotherapy), radiotherapy, surgery, or investigational drugs for the treatment of metastatic pancreatic cancer; Patients who have previously received neoadjuvant or adjuvant chemotherapy could be enrolled if the interval between last treatment and recurrence and metastasis is more than 6 months.
• ）Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• ）Survival is expected to be at least 3 months.
• ）At least one metastatic lesion (non-lymph node lesions with a major diameter of ≥ 10 mm on CT or MRI and lymph node lesions with a minor diameter of ≥ 15 mm) that is measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) and is amenable to accurate repeated measurement. Suspected metastatic lesions (non-regional lymph nodes) that do not meet the above measurable standards and the primary lesions are measurable, the metastatic lesions are confirmed pathologically, can also be included.
• ）The major organs function well: a) white blood cell count ≥ 3.0 × 10\^9/L. b) Hemoglobin ≥ 90.0 g/L. c) Absolute neutrophil count ≥1.5 × 10\^9/L. d) Platelet count ≥100 × 10\^9/L. e) Total bilirubin ≤1.5 × upper limit of normal range (ULN). f) Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 2.5 × ULN; For patients with liver metastasis, ALT, AST and ALP ≤ 5 × ULN; ALP ≤ 10 × ULN in patients with bone metastases.
• g) Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance estimated by Cockcroft Gault formula ≥50 ml/min.
• h) International normalized ratio (INR) ≤ 1.5 × ULN and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
• ）Women of childbearing age are required to have a negative pregnancy test at the screening period and to use a highly effective contraceptive method for 6 months from the screening period to the last dose. Male participants whose partners are women of childbearing age are required to use a highly effective contraceptive method for 6 months after the first dose of a trial product until the last dose.
• ）Patients are able to understand the steps of this trial, are willing to follow the clinical trial protocol to complete the trial, and sign the Informed Consent Form.

You may not qualify if:

• ）Patients who are allergic to the investigational drugs and their analogues, or excipients.
• ）Patients who had any other malignant tumors within 5 years before or at present, except those who had been completely cured, such as basal cell carcinoma, skin squamous cell carcinoma, melanoma in situ, papillary thyroid carcinoma and cervical carcinoma in situ, were excluded.
• ）CNS (central nervous system) or meningeal metastases are known, except for those with single brain metastases that are strictly controlled and asymptomatic.
• ）Patients with tumor liver metastasis exceeding 1/2 of the entire liver during screening; or there may be active hepatitis B (HBsAg test positive, HBV-DNA\>500 IU/ml or research center detection limit \[only when the research center limit is above 500 IU/ml\]); Active hepatitis C (positive for hepatitis C virus (HCV) antibodies and HCV-RNA \> research center detection limit).
• ） Human Immunodeficiency Virus test is positive.
• ）Patients with active, uncontrolled bacterial, viral, or fungal infection requiring current systemic anti-infective therapy.
• ） Patients who have a history of drug or alcohol abuse prior to screening.
• ）Patients with severe organic lesions or major organ failure, such as decompensated heart and lung failure, leading to intolerance to chemotherapy.
• ） Patients with bleeding tendency (e.g., presence of active ulcer lesions in stomach, melena and/or hematemesis within 3 months, hemoptysis).
• ） History of severe cardiovascular and cerebrovascular diseases, including but not limited to:
• NYHA (New York Heart Association) class III or IV heart disease;
• Uncontrollable hypertension (i.e. systolic blood pressure ≥ 160 mmHg, and/or diastolic blood pressure ≥ 100 mmHg)；
• Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc;
• QT interval prolongation corrected for heart rate (corrected for QTc interval using Fridericia formula, males\>450ms, females\>470ms);
• Individuals with significant abnormalities in electrocardiogram with clinical significance;

Sponsors & Collaborators

• Shanghai Yizhong Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201400, China

RECRUITING

MeSH Terms

Interventions

Injections; Gemcitabine; Paclitaxel

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Xiao ya Wang

CONTACT

+86 15601735965; 15601735965@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 31, 2024
• Study Start: February 5, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 10, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)